Comparison of Unilateral or Bilateral Fixation in the Treatment of LFS

Not Applicable

Completed

• Conditions: Lumbar Foraminal Stenosis

• Registration Number: NCT02985138
• Lead Sponsor: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Brief Summary

TLIF is a popular lumbar fusion technique to perform interbody fusion. Pedicle screws providing initial stability have been developed to correct deformity, improve the rate of fusion and speed patient's postoperative recovery. Conventionally, bilateral pedicle screw fixation is a standard approach. Recently, studies have revealed that unilateral pedicle screw fixation provides equivalent clinical outcomes and fusion rates as compared with bilateral pedicle screw fixation in lumbar fusion. Meanwhile, the unilateral approach can reduce intraoperative blood loss and operating time. To our knowledge, few randomized controlled studies comparing unilateral versus bilateral instrumented TLIF in lumbar degenerative diseases have been reported. The purpose of this study is to compare clinical and radiographic outcomes in a series of patients with lumbar foraminal stenosis using instrumented TLIF with unilateral or bilateral pedicle screw fixation.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-11-23
• Study Start: 2016-12
• Study First Submitted QC: 2016-12-04
• Study First Posted: 2016-12-07
• Primary Completion: 2021-09
• Study Completion: 2021-09
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

Inclusion Criteria

Not provided

Exclusion Criteria

• Has systemic infection, highly communicable diseases, inflammatory or autoimmune disease (e.g. osteomyelitis, crohn's, rheumatoid arthritis, systemic lupus, gout, HIV/AIDS, active tuberculosis, venereal disease, active hepatitis).
• Has presence of active malignancy
• Has a history of severe allergy
• Has a significant medical history that, in the investigator's opinion, would not make them a good study candidate.
• Pregnant, or may become pregnant within follow-up period of study
• Has other spinal conditions that will interfere with clinical outcomes (e.g. spinal structural deformities, spinal fractures, ankylosing spondylitis, spinal tuberculosis, spinal infection, spinal tumors, symptomatic cervical spinal disease)
• Spondylolisthesis at the target level
• Has undergone previous lumbar surgery
• Has severe osteoporosis (T-score ≤ -3.5)
• BMI > 35kg/m2
• Has a diagnosis, which requires postoperative medication that interferes with fusion, such as steroids.
• Has history of endocrine or metabolic disorder known to affect osteogenesis (e.g. Paget's disease, renal osteodystrophy, Ehlers-Danios syndrome or osteogenesis imperfecta)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS) scores	2 years postoperatively

Secondary Outcome Measures

Name	Time	Method
Operative duration	1 week postoperatively
Estimated blood loss	1 week postoperatively
Foraminal height	2 years postoperatively	Radiographic parameters
Fusion rate	2 years postoperatively
Adverse events related to procedure	2 years postoperatively
Spinal angles	2 years postoperatively	Radiographic parameters
Oswestry Disability Index (ODI)	2 years postoperatively
Cost of treatment	2 years postoperatively
Length of hospital stay	1 week after discharge
Intervertebral space height	2 years postoperatively	Radiographic parameters

Trial Locations

Locations (1)

Department of Orthopedic Surgery, Shanghai Ninth People's Hospital; 🇨🇳 Shanghai, China